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A Phase II Study of Clofarabine in Patients With Aggressive Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00201669
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : December 6, 2017
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center

Brief Summary:
This study will determine the efficacy of clofarabine as measured by response rate in patients with aggressive non-Hodgkin's lymphoma

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: Clofarabine Phase 2

Detailed Description:

Rationale: Two Food and Drug Administration drugs approved for blood cancers such as non-Hodgkin's lymphoma (NHL) include fludarabine (Fludara) and cladribine (Leustat). The drug offered in the current study, clofarabine was designed to combine the anti-cancer strength of both fludarabine and cladribine. Laboratory research suggests that clofarabine targets anti-cancer mechanisms in cells, helps repair DNA, and inhibits tumor growth. Research also indicates that clofarabine has some efficacy against a variety of blood cancers and solid tumors. Numerous tumor responses have been observed with high doses of clofarabine in heavily pretreated patients with different types of lymphoma. The current study build on this previous research to test clofarabine in patients with aggressive NHL.

Purpose: This study will evaluate the safety and efficacy of clofarabine for aggressive NHL. Toxicities resulting from the combination of clofarabine and the supportive care drug GM-CSF will also be analyzed in patients. GM-CSF is a blood-forming agent that stimulates the production of white blood cells. In addition, several tests, including blood and tumor tissue analysis, will assess immune response and biological changes to the tumor as a result of study drugs.

Treatment: Patients in this study will be given clofarabine through intravenous infusions. This drug will initially be provided to patients for five consecutive days. Several tests will then be conducted and supportive care agents will be administered to stabilize patients' blood cell counts, immune response, and reduce the risk of infection. The first ten patients in this study will be hospitalized until recovery from the first five days of clofarabine to carefully monitor any additional toxicities resulting from the dosing regimen. Patients will receive another five day treatment cycle with clofarabine within seven days after recovering from each previous cycle and no more than four weeks from the start of the previous cycle. Disease response will be measured after every two cycles of treatment with clofarabine. Patient with stable or reduced disease will receive a maximum of six treatment cycles with clofarabine. Treatments will be discontinued due to disease growth, unacceptable side effects, or a treatment delay of more than 21 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Clofarabine in Patients With Aggressive Non-Hodgkin's Lymphoma
Study Start Date : October 2004
Actual Primary Completion Date : May 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Clofarabine

Arm Intervention/treatment
Experimental: Arm I Drug: Clofarabine
Clofarabine 30 mg/m2/day will be administered as a 2-hour intravenous infusion (IVI) on days 1-5.
Other Name: Clolar

Primary Outcome Measures :
  1. Response rate [ Time Frame: up to two years ]

Secondary Outcome Measures :
  1. Determine the toxicity of clofarabine administered in conjunction with growth factor support in patients with relapsed/refractory aggressive NHL. [ Time Frame: up to two years ]
  2. determine the effect of clofarabine on T-, B-, and natural killer (NK)-cell subsets and quantitative immunoglobulin levels after prolonged administration of clofarabine in patients with NHL. [ Time Frame: up to two years ]
  3. Assess cytokine (tumor necrosis factor [TNF]-alpha, interleukin [IL]-6, and IL-10) release following clofarabine therapy. [ Time Frame: up to two years ]
  4. Assess the effect of pre-treatment prognostic factors (p53 mutational status, DNA methylation, and apoptotic protein levels) in patient-derived tumor tissue on response to clofarabine. [ Time Frame: up to two years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must have histologically confirmed aggressive NHL
  • B-cell NHL must be relapsed/ refractory
  • T-cell & NK-cell and transformed lymphoma eligible at DX
  • Patients with B-cell NHL (ie, diffuse large B-cell lymphoma, mantle cell lymphoma, and Burkitt's lymphoma) must have relapsed or refractory disease after at least 1 prior therapy.
  • Patients previously treated with radioimmunotherapy (ie, ibritumomab tiuxetan [Zevalin] or tositumomab [Bexxar]) or prior stem cell transplant (SCT) are eligible.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Life expectancy of at least 12 weeks.
  • Laboratory values obtained ≤ 7 days prior to registration:

    • Absolute neutrophil count (ANC) ≥ 1500/mm3
    • Platelets ≥ 100,000/mm3
    • Total bilirubin ≤ upper limit of normal (ULN)
    • Alkaline phosphatase ≤ 2 × ULN
    • Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 2 × ULN
    • Serum creatinine ≤ ULN

Exclusion Criteria:

  • No prior treatment with clofarabine.
  • Full recovery from all acute toxicities associated with prior chemotherapy, radiotherapy, or immunotherapy.- Patients with active, uncontrolled systemic infection considered to be opportunistic, life threatening, or clinically significant at the time of treatment or with a known or suspected fungal infection (ie, patients on parenteral antifungal therapy) are not eligible.
  • Cardiac function (i.e. left ventricular ejection fraction) ≥ 50% on pretreatment radionuclide ventriculography (RVG) or echocardiogram.
  • Women that are pregnant or breastfeeding.
  • Known HIV disease.
  • No CNS lymphoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00201669

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United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
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Principal Investigator: Kristie Blum Ohio State University
Additional Information:
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Responsible Party: Ohio State University Comprehensive Cancer Center Identifier: NCT00201669    
Other Study ID Numbers: OSU-0442
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Keywords provided by Ohio State University Comprehensive Cancer Center:
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Behavioral Symptoms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents